BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M2A 38MM MOD HD +3MM NK

    MDR report key: 2829583 · Received November 13, 2012

    Report

    Report Number
    0001825034-2012-02398
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    January 12, 2004
    Report Date
    October 17, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWA
    PMA / PMN Number
    PK011110
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. EXPIRATION DATE - UNKNOWN. MANUFACTURE DATE - UNKNOWN. THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. THIS REPORT IS NUMBER 1 OF 5 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-002398 / 02402). THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: UNDER WARNINGS, IT STATES, "IMPROPER SELECTION, PLACEMENT, POSITIONING, ALIGNMENT AND FIXATION OF THE IMPLANT COMPONENTS MAY RESULT IN UNUSUAL STRESS CONDITIONS WHICH MAY LEAD TO SUBSEQUENT REDUCTION IN THE SERVICE LIFE OF THE PROSTHETIC COMPONENTS. MALALIGNMENT OF THE COMPONENTS OR INACCURATE IMPLANTATION MAY LEAD TO EXCESSIVE WEAR AND/OR FAILURE OF THE IMPLANT OR PROCEDURE." THIS REPORT IS NUMBER 1 OF 4 MDRS FILED FOR THE SAME PATIENT (REFERENCE 1825034-2012-02398/ 02399 & 2013-02901/02902). ADDITIONAL MEDWATCHES FOR THIS PATIENT WERE REPORTED ON MEDWATCH NUMBERS 1825034-2012-02400/2402.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2003. A SUBSEQUENT REVISION PROCEDURE WAS ALLEGEDLY PERFORMED ON (B)(6) 2004 AND FURTHER REVISION ALLEGEDLY PERFORMED ON (B)(6) 2008 DUE TO ALLEGED PAIN, ELEVATED METAL ION LEVELS, INFLAMMATION AND COMPLICATIONS WITH WALKING AND STAIRS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF'S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR THE PATIENT ALLEGES THAT PATIENT UNDERWENT RIGHT TOTAL HIP ARTHROPLASTY (B)(6) 2003. A SUBSEQUENT REVISION PROCEDURE WAS ALLEGEDLY PERFORMED (B)(6) 2004 AND FURTHER REVISION ALLEGEDLY PERFORMED ON (B)(6) 2008 DUE TO ALLEGED PAIN, ELEVATED METAL ION LEVELS, INFLAMMATION AND COMPLICATIONS WITH WALKING AND STAIRS. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. ADDITIONAL INFORMATION RECEIVED IN PATIENT MEDICAL RECORDS INDICATES THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2004 WAS DUE TO LEG LENGTH DISCREPANCY. THE OPERATIVE NOTES CONFIRM THAT THE MODULAR HEAD WAS REMOVED AND REPLACED. MEDICAL RECORDS ALSO INDICATE THAT THE REVISION PROCEDURE THAT TOOK PLACE ON (B)(6) 2008 WAS DUE TO METALLOSIS, INSTABILITY AND A RETROVERTED ACETABULAR COMPONENT. THE OPERATIVE NOTES CONFIRM THAT THE ACETABULAR CUP, MODULAR HEAD AND FEMORAL COMPONENT WERE REMOVED AND REPLACED. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M2A 38MM MOD HD +3MM NK PROSTHESIS, HIP KWA BIOMET ORTHOPEDICS N/A 628570

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R